Fixation devices for catheters

ABSTRACT

Fixation devices are disclosed herein that can be used to secure to a catheter. The fixation devices include a body having a central bore extending therethrough to receive a catheter and at least one end having a tapered profile tapering inwardly a distal edge thereof. The body can include an expanded intermediate portion, such as one or more bulbous portions. The fixation devices can also include suture openings or grooves to secure the devices to tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/804,032, filed Feb. 11, 2019, and U.S. Provisional Application No.62/892,743, filed Aug. 28, 2019, which are incorporated by referenceherein in their entireties.

FIELD OF THE DISCLOSURE

The present disclosure generally relates to catheters and, moreparticularly, to fixation devices for catheters.

BACKGROUND

Applying sutures directly around an implantation opening for a catheterin the tissue of a patient can risk suture rupture, catheter lumencollapse, or even catheter tear, depending on the materials used for thecatheter and the suture. These failures could, in turn, undesirably leadto catheter migration. For applications, such as intrathecal catheters,having long-term implantation and life, these risks may be furtheramplified.

SUMMARY

In accordance with a first aspect, a fixation device for a catheter isdescribed herein that includes an elongate body having a central boreextending therethrough. An intermediate portion of the body has anexpanded configuration and an end of the body has a tapered profile thattapers inwardly from the intermediate portion to a distal edge thereof.

According to some forms, the fixation device can include one or more ofthe following aspects: the body can include inwardly projecting catheterengagement protrusions; the expanded configuration can include a bulbousportion that extends outwardly from a generally central location of thebody; the expanded configuration includes a plurality of bulbousportions giving the body an undulating outer surface; the end of theelongate body can be angled with respect to a longitudinal axis of thebody or flexible, such that the end is adapted to be used as a plug inan opening in tissue; the body can be symmetrical, such that an oppositeend of the body has a tapered profile tapering inwardly from theintermediate portion to a distal edge thereof; or the body can includeone or more slot openings extending radially therethrough to the centralbore.

According to some forms, the fixation device can include at least onetab that projects outwardly from the body and has a suture openingextending therethrough. In further forms, the at least one tab can be aplurality of tabs that are arrayed in an asymmetrical pattern about thebody or the at least one tab can be a circular flange that extendsoutwardly from the body and has openings arranged about a circumferencethereof. In one version, the circular flange can include slots thatextend radially inwardly from edges thereof to define wedge portionsthat are adapted to be flexed to desired positions around a catheter.

According to some forms, the fixation device can further include a valvethat extends across the central bore and is adapted to engage a catheterinserted therethrough to restrict movement of the catheter. In furtherforms, the central bore can include an expanded intermediate portion toallow portions of the valve to deflect therein due to a catheter beinginserted therethrough. Moreover, the valve can be a one way valve or atoggle valve.

According to some forms, the body can include a longitudinal openingextending along at least a portion thereof; and the fixation device canfurther include opposing wings that extend laterally outwardly fromedges of the longitudinal opening, where the wings are adapted to besecured together. In further forms, the wings can include opposinglongitudinally opening slots that extend adjacent to the body, such thatthe wings are configured to latch together by interlocking the slots orthe wings can be a male wing and a female wing, where the female wingincludes a coupling slot that extend longitudinally across a widththereof and the male wing includes a notched portion having a widthsized to fit within the coupling slot. In one version, the female wingcan further include a second slot that extends laterally from thecoupling slot, where the second slot is sized to receive the male wingtherethrough so that the notched portion can be positioned within thecoupling slot.

According to some forms, the body can include one or more groovesextending around at least a portion thereof. In further forms, thefixation device can include a clamp member having one or moreprotrusions that are adapted to be inserted into the one or more groovesas the clamp member is secured around the body. The clamp member can beconfigured to compress the body around a catheter inserted therethrough.

In accordance with a second aspect, a fixation device for a catheter isdescribed that includes an elongate band having a suture openingextending therethrough. The elongate band includes a female end having acoupling opening extending therethrough and an opposite, male end. Aretention portion of the male end is configured to be inserted into thecoupling opening of the female end to thereby secure the elongate bandaround a catheter.

According to some forms, the elongate band can have a rigidconfiguration with the male end curved back over the female end todefine an open bore to receive a catheter therein and the retentionportion can be configured to snap-fit within the slot opening with themale end flexed toward the female end to secure the elongate band to thecatheter.

According to some forms, the elongate band can be a first elongate bandand the device can include a second elongate band having a sutureopening extending therethrough and a central strip extendinglongitudinally between and connecting the first and second elongatebands together. The second elongate band can include a female end havinga coupling opening extending therethrough and an opposite, male end. Aretention portion of the male end of the second elongate band can beconfigured to be inserted into the slot opening of the female end tothereby secure the second elongate band around a catheter. The devicecan be configured so that the male ends of the first and second elongatebands are disposed on opposite sides of the central strip, such that thedevice defines a tortuous path for the catheter with the retentionportions secured within the respective coupling openings.

According to any of the above forms, a catheter engagement portion ofthe elongate band can include textured surfaces.

In accordance with a third aspect, a fixation device for a catheter isdescribed herein that includes a sleeve member having a central portionand a bore extending longitudinally therethrough. The fixation devicefurther includes a collar member having an annular body sized to fitover and compress the central portion of the sleeve member and one ormore tabs that extend outwardly from the collar member. The one or moretabs each have a suture opening extending therethrough.

According to some forms, the sleeve member can include a longitudinalslit that extends through a side thereof to the bore, such that thesleeve member can be longitudinally opened to be disposed around acatheter.

According to some forms, the sleeve member can include barbed retentionends on opposite sides of the central portion. In further forms, thecollar member can include portions spaced longitudinally from theretention ends of the sleeve member to define suture gaps therebetweenwith the collar member mounted therearound; and/or the retention endscan have inwardly tapered profiles.

BRIEF DESCRIPTION OF THE DRAWINGS

The above needs are at least partially met through provision of theembodiments described in the following detailed description,particularly when studied in conjunction with the drawings, wherein:

FIG. 1 is a sectional view of a first example fixation device for acatheter in accordance with various embodiments;

FIG. 2 is a cross-sectional view of the fixation device of FIG. 1;

FIG. 3 is a sectional view of a second example fixation device for acatheter in accordance with various embodiments;

FIG. 4 is a schematic perspective view of a third example fixationdevice for a catheter in accordance with various embodiments;

FIG. 5 is a cross-sectional view of the fixation device of FIG. 4;

FIG. 6 is a cross-sectional view of an alternative outer member for thefixation device of FIG. 4;

FIG. 7 is a perspective view of a fourth example fixation device for acatheter in accordance with various embodiments;

FIG. 8 is an exploded view of a fifth example fixation device for acatheter in accordance with various embodiments;

FIG. 9 is a side elevational view of the fixation device of FIG. 8 in anassembled configuration;

FIG. 10 is a top plan view of a sixth example fixation device for acatheter in accordance with various embodiments;

FIG. 11 is a top plan view of the fixation device of FIG. 10 in an openconfiguration;

FIG. 12 is a front elevational view of the fixation device of FIG. 10;

FIG. 13 is a perspective view of a seventh example fixation device for acatheter in accordance with various embodiments;

FIG. 14 is a perspective view of a eighth example fixation device for acatheter in accordance with various embodiments;

FIG. 15 is a perspective view of a ninth example fixation device for acatheter in accordance with various embodiments;

FIG. 16 is a perspective view of an tenth example fixation device for acatheter in accordance with various embodiments;

FIG. 17 is a perspective view of a eleventh example fixation device fora catheter in accordance with various embodiments;

FIG. 18 is a perspective view of a twelfth example fixation device for acatheter in accordance with various embodiments;

FIG. 19 is a perspective view of an thirteenth example fixation devicefor a catheter in accordance with various embodiments;

FIG. 20 is a perspective view of a fourteenth example fixation devicefor a catheter in accordance with various embodiments;

FIG. 21 is a perspective view of a fifteenth example fixation device fora catheter in accordance with various embodiments;

FIG. 22 is a top plan view of the fixation device of FIG. 21;

FIG. 23 is a perspective view of a sixteenth example fixation device fora catheter in accordance with various embodiments;

FIG. 24 is a side elevational view of the fixation device of FIG. 23 ina closed configuration;

FIG. 25 is a top plan view of a seventeenth example fixation device fora catheter in accordance with various embodiments;

FIG. 26 is a top plan view of the fixation device of FIG. 25 in a closedconfiguration;

FIG. 27 side elevational view of the fixation device of FIG. 25 in aclosed configuration;

FIG. 28 is a top plan view of a eighteenth example fixation device for acatheter in accordance with various embodiments;

FIG. 29 is a cross-sectional view of the fixation device of FIG. 28taken along the line 29-29;

FIG. 30 is a cross-sectional view of the fixation device of FIG. 28taken along the line 30-30;

FIG. 31 is a sectional view of a portion of FIG. 30;

FIG. 32 is a cross-sectional view of a nineteenth example fixationdevice for a catheter in accordance with various embodiments;

FIG. 33 is a cross-sectional view of a twentieth example fixation devicefor a catheter in accordance with various embodiments;

FIG. 34 is a perspective view of a clamping member for the fixationdevice of FIG. 33;

FIG. 35 is a cross-sectional view of a twenty first example fixationdevice for a catheter in accordance with various embodiments;

FIG. 36 is a top plan view of a twenty second example fixation devicefor a catheter in accordance with various embodiments;

FIG. 37 is a top plan view of the fixation device of FIG. 36 havingsuture tabs in a bent configuration;

FIG. 38 is a top plan view of the fixation device of FIG. 36 having adistal tip in a bent configuration;

FIG. 39 is a sectional view of the fixation device of FIG. 36 having adistal tip in a bent configuration;

FIG. 40 is a top plan view of the fixation device of FIG. 36 in an openconfiguration;

FIG. 41 is a perspective view of an twenty third example fixation devicefor a catheter in accordance with various embodiments;

FIG. 42 is a cross-sectional view of the fixation device of FIG. 41;

FIG. 43 is a perspective view of a twenty fourth example fixation devicefor a catheter in accordance with various embodiments;

FIG. 44 is a cross-sectional view of the fixation device of FIG. 43;

FIG. 45 is a perspective view of a twenty fifth example fixation devicefor a catheter in accordance with various embodiments;

FIG. 46 is a top plan view of the fixation device of FIG. 45;

FIG. 47 is a top plan view of an alternative suture disc configurationfor the fixation device of FIG. 45;

FIG. 48 is a perspective view of a twenty sixth example fixation devicefor a catheter in accordance with various embodiments; and

FIG. 49 is a cross-sectional view of the fixation device of FIG. 48.

DETAILED DESCRIPTION

Fixation devices, which can include fixation tabs, suture wings, oranchoring wings, are disclosed herein that can be used to secure to acatheter and optionally secure a catheter in place with the use ofsutures. The fixation devices can aid in preventing catheter migrationor dislodgement from an implantation site. For intrathecal applications,the fixation devices disclosed herein can be implantable for relativelylong-term periods to secure or anchor the catheter to the fascia of thepatient after the catheter has been implanted in the intrathecal space.In one approach, a tip of the fixation device can be used to plug theopening in the dura at the insertion site.

The fixation devices disclosed herein can advantageously provide one ormore of the following aspects: fit snugly over the outer diameter of thecatheter without compressing the catheter's inner diameter, not relysolely on sutures for securing onto the catheter, stay in place oncesecured without sliding back and forth regardless of wet conditions,anchor the catheter to the fascia with the use of sutures, serve to plugthe hole at the dura to reduce the risk of cerebrospinal fluid (CSF)leakage, not stick out perpendicularly to the fascia in a way that couldlead to tissue erosion, withstand sutures without breaking or abrading,be radiopaque, be safe, biocompatible, and long-lasting to function as along-term implantable device, be able to be used at any desiredanchoring site, including, for example, at the dura, away from the dura,and in the subcutaneous port pocket, and be suitable for massmanufacture. In some versions, the fixation devices described herein canfurther provide one or more of the following aspects: be able to berepositioned once placed, be able to be placed without the use of adispensing tool, be symmetrical so that a user can place the devicewithout concern about orientation and so that the device does not haveto be removed and redeployed after it has been deployed.

A first example fixation device 100 is shown in FIGS. 1 to 3. Thefixation device 100 of this form includes an elongate body 102 with aproximal end 104 and a distal end 106. The body 102 has an outwardlybulging intermediate or central portion 108. The bulging portion 108 canpreferably have a curved or tapered profile so that the body 102 has asmooth outer surface 110 transitioning from the proximal end 104, overthe bulging portion 108, and to the distal end 106. The tapered profileof the body 102 extending to the distal end 106 from the intermediateportion 108 can advantageously be utilized to act as a plug when a userinserts the distal end 106 into the opening through the dura of apatient. The inwardly tapered profile of the distal end 106 seals withthe dura in the opening therethrough to prevent or minimize the leakageof CSF. If desired, the body 102 can be symmetrical so that the proximaland distal ends 104, 106 have similarly tapered profiles and can each beused as a plug. This allows a user to implant the device 100 withouthaving to worry about orientation.

In one version, the bulging portion 108 includes wings 112 extendinglaterally outwardly on opposite sides of the body 102. In anotherversion, the bulging portion 108 can extend around an entirecircumference of the body 102. The bulging portion 108 further includessuture openings 114 that extend generally transverse to a longitudinalaxis L of the body 102. In an alternative version as shown in FIG. 3,the body can further include tabs 116 extending outwardly from oppositesides of the body 102 and on the distal end side of the bulging portion108. In this form, the tabs 116 include the suture openings 114. Thetabs 116 are longitudinally spaced from the distal end 106 so that theend 106 can be utilized as a plug as described above.

Turning now to FIG. 2, the body 102 includes a central bore 118extending longitudinally therethrough along the longitudinal axis L thatis sized to receive a catheter 10. While the device 100 may be suitablefor many purposes in this form, the device 100 can further include oneor more one-way valves 120 extending across the inner diameter of thecentral bore 118. The valves 120 are configured to allow the catheter 10to only move in a single direction therethrough and, thus, through thebody 102. Accordingly, the valves 120 allow a user to insert thecatheter 10 through the body 102, but thereafter resist or preventretrograde slippage of the catheter 10 through the device 100.

With any of the above versions, after a user has implanted the catheter10, a user can then advance the fixation device 100 over the catheter 10to a final desired position. Then, the user can suture the device 100 inplace using the openings 114 to prevent the catheter 10 from migrating.The device 100 can be sutured in any desired location, including to thefascia at the site of the dura entry, away from the dura, e.g., Scarpa'sfascia, in a port pocket, and so forth.

Another example fixation device 200 is shown in FIGS. 4 to 6. Thefixation device 200 of this form has a two-piece design with an innersleeve member 202 and an outer collar member 204. The sleeve 202 andcollar 204 can be used in combination to create a seal around a catheter10 to thereby prevent fluid from passing around the catheter 10 or allowthe catheter 10 to move axially with respect to the device 200.

The sleeve 202 includes a central cylindrical body 206 with outwardlyextending barbed retention portions 208 at proximal and distal ends 210,212 thereof. In the illustrated form, the retention portions 208 havefrusto-conical shapes oriented so that the retention portions 208 taperradially inwardly towards ends of the sleeve 202. Of course, othershapes can be utilized, including cylindrical, curved, and so forth. Asshown, the sleeve 202 includes a central bore 214 extendinglongitudinally therethrough along a longitudinal axis L that is sized toreceive a catheter 10.

The sleeve 202 can be composed of a soft flexible material, such as alow durometer silicone, that allows a user to resiliently deform thesleeve 202 for implantation. In one form, the sleeve 202 can include alongitudinal slit 216 that extends radially through a side of the sleeve202 to the central bore 214. With this configuration, a user canseparate the sleeve 202 along the slit 216 to thereby position thecatheter 10 within the central bore 214 at a desired location of thecatheter 10. Thereafter, the sleeve 202 will resiliently return to itsoriginal shape so that the sleeve 202 extends around the catheter 10. Inanother form, the sleeve 202 can be advanced along the length of thecatheter 10 until a desired location is reached, instead of using theslit 216.

The collar 204 includes an annular body 218 with a central bore 220extending therethrough and tabs 222 extending laterally from the body218. The tabs 222 each include a suture opening 224 extendingtherethrough. The collar 204 can be composed of a soft flexiblematerial, such as a medium to higher durometer silicone, so that a usercan stretch the collar over the sleeve 202 to assemble the fixturedevice 200. Further, the collar 204 can be sufficiently resilient toprovide a sufficient amount of hoop stress on the sleeve 202 to seal offand hold the catheter 10 within the device 200. In one form, the body218 of the collar 204 can be sized so that a length thereof is equal toor slightly, e.g., between about 1 mm to about 5 mm or between about 1mm to about 3 mm, smaller than a distance between the retention portions208 of the sleeve 202. In another form as shown in FIG. 5, the body 218of the collar 204 can be sized so that ends 226 of the body 218 arespaced from the retention portions 208 by gaps 228. These gaps 228advantageously provide a protected and secure location to receivesutures or ligatures 230 to secure the fixture device 200 to a patient'stissue at a desired location, such as to the facia at the site of thedura entry, away from the dura, e.g., Scarpa's facia, in a port pocket,and so forth. In another form as shown in FIG. 6, the collar 204 caninclude an intermediate portion 232 that extends radially outwardly fromadjacent portions of the collar 204. Further, the body 218 can have alength equal to or slightly smaller than the distance between theretention portions 208 of the sleeve 202. With this configuration, gaps234 are created between the intermediate portion 232 and the respectiveretention portion 208 of the sleeve 202, while the longitudinal ends ofthe sleeve 202 extend across bottoms of the gaps 234. This arrangementprevents sutures or ligatures 230 from directly contacting the sleeve202.

So configured, a user can position the sleeve 202 at a desired locationon the catheter 10, either by threading the sleeve 216 along the lengthof the catheter or by installing the sleeve 202 on the catheter with theslit 216. After the sleeve 202 is placed at the desired location, a usercan then thread the collar 204 from the proximal end of the catheter 10down to the sleeve 202. Then the user can deform the collar 204 andplace the collar 204 into position between the retention ends 208 of thesleeve 202. An outer diameter of the sleeve 202 and an inner diameter ofthe collar 204 can advantageously be sized and configured to create aninterference fit that provides a desired hold on the catheter 10 torestrict or prevent the catheter 10 from migrating. The user can thenplace sutures through the openings 224 to fix or secure the assembly tosurrounding tissue and/or place sutures through the gaps 228, 234. In analternative form, the sleeve 202 can include tabs that project outwardlyof the collar 204 with suture openings. Moreover, the fixture device 200can be provided with a deployment tool (not shown) that aids instretching the collar 204 over the sleeve 202 and/or placing theassembled fixture device into surgically hard to reach locations. Thesleeve 202 and/or collar 204, or portions thereof, can be loaded withbarium sulphate (BaSO4) or other suitable radiopaque material so thatthe radiopaque portions can be imaged using conventional X-raytechniques.

In another example shown in FIG. 7, a fixation device 200′ can include asleeve 202′ with only a central cylindrical body 206′ without the barbedretention portions 208. As shown, the sleeve 202′ can include a centralbore 214′ extending longitudinally therethrough along the longitudinalaxis L that is sized to receive a catheter 10. In this form, an outerdiameter of the sleeve 202′ and an inner diameter of a collar 204′ canadvantageously be sized and configured to create an interference fitthat provides a desired hold on the catheter 10 to restrict or preventthe catheter 10 from migrating. The user can then place sutures throughone or more openings 224′ to fix or secure the assembly to surroundingtissue. If desired, the sleeve 202′ can have a longitudinal slit and aclamshell configuration with a longitudinal hinged connection 240 or canhave a two-piece construction, so that the sleeve 202′ can be positionedon the catheter 10 at a desired location and the collar 204′ can bedisposed over the sleeve 202′ to couple the device 200′ to the catheter10.

In yet another example, a fixation device 250 is shown in FIGS. 8 and 9.The fixation device 250 of this form has a two-piece design with aninner sleeve member 252 and an outer collar member 254. The sleeve 252and collar 254 can be used in combination to create a seal around acatheter 10 to thereby prevent fluid from passing around the catheter 10or allow the catheter 10 to move axially with respect to the device 250.

The sleeve 252 includes a generally cylindrical body 256 with anoutwardly extending barbed retention portion 258 at a proximal end 260.As shown, the retention portion 258 has an increased diameter relativeto an intermediate portion 262 of the sleeve 252. With thisconfiguration, the retention portion 258 prevents the collar 254 frommigrating off of the proximal end 260 of the sleeve 252. If desired, theretention portion 258 can have a frusto-conical shape oriented so thatthe retention portion 258 tapers radially inwardly towards ends of thesleeve 252. Of course, other shapes can be utilized, includingcylindrical, curved, and so forth.

The collar 254 includes an annular body 264 with a central bore 266extending therethrough. If desired, the collar 254 can include tabs,configured similar to the above forms, that extend laterally from thebody 264 and include a suture opening. The collar 254 can be composed ofa soft flexible material, such as a medium to higher durometer silicone,so that a user can stretch the collar 254 over the sleeve 252 toassemble the fixture device 250. Further, the collar 254 can besufficiently resilient to provide a sufficient amount of hoop stress onthe sleeve 252 to seal off and hold the catheter 10 within the device250.

A distal end 268 of the sleeve 252 has a longitudinally segmentedconfiguration with a plurality of spaced-apart members 270, such asthree or four members, forming the distal end 268. As shown, the sleeve252 includes a central bore 272 extending longitudinally therethroughalong a longitudinal axis L that is sized to receive a catheter 10. In aresting configuration, the members 270 can define a diametertherebetween for the central bore 272 that allows the catheter 10 to beslid through the sleeve 252 to allow a user to position the sleeve 252on a desired portion of the catheter 10. Moreover, each of the members270 can include an outwardly extending finger 274 configured so that thecollar 254 is retained between the fingers 274 and the retention portion258. By one approach, the fingers 274 can be angled to extend rearwardlyalong the sleeve 252 toward the proximal end 260 thereof. With thisconfiguration, and the flexible nature of sleeve 252 with thespaced-apart members 270, the collar 254 can deflect the fingers 274when the collar 254 is mounted to the sleeve 252. The deflection of thefingers 274 drives the members 270 inwardly to compress onto thecatheter 10, which causes the fixation device 250 to secure to thecatheter 10. An amount of deflection can be controlled by the stiffnessof the material of the sleeve 252, including the members 270 and fingers274, and the size of the fingers 274 relative to the collar 254 and thespacing between the fingers 274 and the retention portion 258.

Another example fixation device 300 is shown in FIGS. 10 to 12. Thefixation device 300 of this form includes an elongate main body 302 witha proximal end 304 and a distal end 306. The body 302 has an outwardlybulging intermediate or central portion 308. The bulging portion 308 canpreferably have a curved or tapered profile so that the body 302 has asmooth outer surface 310 transitioning from the proximal end 304, overthe bulging portion 308, and to the distal end 306. The tapered profileof the body 302 extending to the distal end 306 can advantageously beutilized to act as a plug when a user inserts the distal end 306 intothe opening through the dura of a patient. The inwardly tapered profileof the distal end 306 seals with the dura in the opening therethrough toprevent or minimize the leakage of CSF. If desired, the body 302 can besymmetrical so that the proximal and distal ends 304, 306 have similarlytapered profiles and can each be used as a plug. This allows a user toimplant the device 300 without having to worry about orientation.Moreover, in some versions, one or both of the ends 304, 306 can beangled with respect to horizontal so that the end 304, 306 can extendinto the dura opening while the remaining portion of the body 302extends along or lies flat against the fascia.

As shown in FIGS. 10 to 12, the body 302 further includes a slit oropening 312 extending along a longitudinal length thereof so that thebody 302 can be opened to expose an interior bore 314. In some versions,the body 302 can include teeth, ribs, or other textured surfaces 315running along a portion of the interior bore 314 to grip a catheter 10inserted therein. This configuration allows a user to place the body 302around a desired portion of the catheter 10 without having to thread thebody 302 along a length thereof.

The fixation device 300 further includes tabs or wings 316 that extendoutwardly from opposite sides of the opening 312 in a generally centrallocation. As shown in FIG. 11, connections between the tabs 312 and thebody 302 include longitudinally opening slits 318. Specifically, one ofthe connections includes a slit 318 that opens towards the proximal end304 and the other one of the connections includes a slit 318 that openstowards the distal end 306. With this configuration, a user can wrap thebody 302 around the catheter 10 and latch the slits 318 to lock the tabs316 together. Moreover, as the tabs 316 are pulled in oppositedirections to latch the slits 318, the body 302 tightens around thecatheter 10 causing the teeth 315 to press against the outer diameter ofthe catheter 10. Outer tips 320 of the tabs 318 can include openings 322extending therethrough to receive sutures to secure the fixture device300 to tissue. A further suture can be added around the tabs 316 toprevent them from coming apart.

Additional example fixation devices 400 are shown in FIGS. 13 to 20. Thefixation devices 400 of these forms include a variety of structuralfeatures and functionalities that can be used individually or incombination with each other to achieve the design intent of sealing tothe outer diameter of the catheter to prevent fluid from leaking betweenthe fixation device 400 and catheter and/or to hold or secure thecatheter in place.

In some examples, the fixture devices 400 have bodies 402 having acentral bore 403 extending longitudinally therethrough to receive acatheter. The bodies 402 can include bulbous or ring-shaped portions 404in single or multiple profiles that act as a plug to seal or preventfluid leaks, such as a CSF leak from the opening through the dura. Forexample, as shown in the devices 400 of FIGS. 14-16 and 18-20, the body402 can include bulbous portions 404 on either side of a body center,giving the body 402 a symmetric shape. The bulbous portions 404 can beused in combination with tapered end sections 406 that taper down toproximal and distal ends 408, 410 of the bodies 402. As shown, thetapered end sections 406 taper downwardly so that tips 412 thereof areslightly, e.g., between about 1 mm to 3 mm, larger than an outerdiameter of the catheter due to a wall thickness of the body 402.

The fixture devices 400 can also include outwardly extending tabs 414having openings 416 extending therethrough that allow for easy placementof sutures to secure the fixation devices 400 and catheter tosurrounding tissue. One or two tabs 414 can be centrally located alongthe body 402, shown in the device 400 of FIGS. 13 and 19, for example,and/or can be located adjacent to one or both of the proximal and distalends 408, 410, shown in devices 400 of FIGS. 17, 18, and 20. As shown,the tabs 414 can be provided in singular or in multiple locations or inopposing or asymmetric locations. Further, the tabs 414 can be extendfrom adjacent bulbous portions 404 in a web-like matter.

In some versions, the devices 400 can also include slots or cut-outs 418that extend through the body 402 to the central bore 403. The slots 418extend along an intermediate portion of the body 402 between theproximal and distal ends 408, 410. The devices 400 can include one slot418, opposing slots 418 as shown in FIG. 13, four slots 418 disposedsymmetrically around the body 402 as shown in FIG. 15, six slots 418disposed symmetrically around the body 402 as shown in FIG. 16, or othernumbers or patterns. The slots 418 allow for the catheter to bevisualized therethrough and/or can be used to receive a suture orligature to fix the device 400 to tissue and/or tighten around thecatheter to increase the hold or sealing of the catheter within thedevice 400.

Another example fixation device 500 is shown in FIGS. 21 and 22. Thefixation device 500 of this form includes a body 502 having catheterreception portions 504 spaced apart by and opposing one another over atransverse band 506. In the illustrated form, the catheter receptionportions 504 have outwardly oriented frusto-conical shapes with centralbores 508 extending longitudinally therethrough. Of course, other shapescan alternatively be utilized. The configuration of the device 500allows the device to lie flat when implanted.

As shown, the band 506 includes a central portion 510 disposed betweenthe catheter reception portions 504 that includes upwardly protrudingribs 512 or other textured surfaces to engage a catheter. The ribs 512extend in a longitudinal direction and are spaced transversely from oneanother. The band 506 further includes tabs or wings 514 that projectlaterally outwardly from the central portion 510. Each of the tabs 514includes an opening 516 extending therethrough for reception of a sutureto fix the device 500 to tissue.

To tighten the device 500 around a catheter, one of the tabs 514 is afemale tab with a slot opening 518 extending therethrough and the otherof the tabs 514 is a male tab including first and second waistedportions or notches 520, 522. One or more than two notches canalternatively be utilized. As shown, the slot opening 518 of the femaletab 514 has a length generally equal to or slightly larger than thenotches 520, 522 of the male tab 514, but smaller than a width of theremaining portions of the male tab 514. With this configuration, a usercan bend the tabs 514 toward one another over the central portion 510and resiliently deform the slot opening 518 and/or male tab 514 untilthe first notch 520 is received within the slot opening 518. Thereafter,when a user desires to secure the catheter within the device 500, theuser can pull on the male tab 514 until the second notch 522 is receivedwithin the slot opening 518. As the tabs 514 are tightened together theribs 512 engage the catheter around a circumference thereof to preventthe catheter from migrating without the use of a suture. As with theabove forms, one of the reception portions 504 can be utilized as a plugto seal with the dura in the opening therethrough to prevent CSFleakage. Of course, it will be understood that the device 500 could beprovided without the catheter reception portions 504, leaving the band506. In one form, the body 502 can be composed of silicone 50A.

In one example shown in FIGS. 23 and 24, a fixation device 500′ caninclude a body 502′ without the catheter reception portions 504. In thisform, the body 502′ is a transverse band 506′ with at least one end orwing 514′ having an opening 516′ extending therethrough for reception ofa suture to fix the device 500′ to tissue. To tighten the device 500′around a catheter, one of the ends 514′ is a female tab with a slotopening 518′ extending therethrough and the other of the ends 514′ is amale tab including a plug 519 with a waisted portion 520′. As shown, theslot opening 518′ of the female tab 514′ has a length generally equal toor slightly larger than the waisted portion 520′ of the male tab 514′,but smaller than a width of the remaining portion of the plug 514.

By one approach, the body 502′ can be flexible. With this configuration,a user can bend the ends 514′ toward one another over a central portion510′ of the band 506′ and resiliently deform the slot opening 518′and/or plug 519 until the waisted portion 520′ is received within theslot opening 518′. If desired, the body 502′ can include ribs configuredsimilarly to the above form, to engage the catheter 10 around acircumference thereof to prevent the catheter 10 from migrating withoutthe use of a suture. By another approach, the body 502′ can be rigidwith a looped configuration as shown where the male end 514′ is spacedfrom the slot opening 518′ and the body 502′ defines a bore 521 toreceive the catheter 10 therethrough. With this configuration, the auser can insert the catheter 10 through the bore 521, position thedevice 500′ at a desired point along the catheter 10, and resilientlyflex the body 502 to insert the plug 519 into the slot opening 518′. Theplug 521 can be configured to snap-fit within the opening 518′ to holdthe ends 514′ together with the body 502′ compressed around an entireperimeter of the catheter 10.

In yet another example shown in FIGS. 25 to 27, a fixation device 530similar to the above forms can include a body 532 without the catheterreception portions 504. In this form, the body 532 includes a pair ofstacked transverse bands 534 connected to one another by a central strip536. Each band 534 includes tabs 538 that project laterally outwardlyfrom the central strip 536. To tighten the bands 534 around a catheter,one of the tabs 538 is a female tab with a slot opening 540 extendingtherethrough and the other of the tabs 538 is a male tab including aretention portion 542. By one approach, the retention portion 542 can bea plurality of ribs as shown that project upwardly from the male tab538. As shown, the slot opening 540 of the female tab 538 has a lengthgenerally equal to or slightly larger than the male tab 538 and a heightgenerally equal to or slightly larger than the male tab 538. With thisconfiguration, a user can bend the tabs 538 of each of the bands 534toward one another over the central strip 536 and resiliently deform theslot opening 540 and/or male tab 538 until one of the ribs 542 areforced through the slot opening 540. The rib 542 engages the female tab538 and holds the respective band 534 in a looped configuration.Thereafter, when a user desires to secure the catheter 10 within thedevice 530, the user can pull on the male tab 538 until a subsequent rib542 is received through the slot opening 540. As the tabs 538 aretightened together the body 532 is wrapped around the catheter 10 arounda circumference thereof to prevent the catheter from migrating withoutthe use of a suture. By another approach, the retention portion 542 caninclude first and second waisted portions or notches similar to theabove form. If desired, the central strip 536 can include ribs similarto the above form.

As shown, the bands 534 can be disposed in flipped relation to oneanother such that the male tabs 538 are disposed on opposite sides ofthe central strip 536. Advantageously, this configuration can beutilized to apply opposing forces on the catheter 10 when the device 530is tightened thereto and sutured to tissue through openings 544extending through ends of the male tabs 538. These opposing forces andthe resulting tortuous S-shaped path, along with the compression of thebands 534, hold the catheter 10 in a desired location.

Another example fixation device 550 is shown in FIGS. 28 to 31. Thefixation device 550 of this form includes a body 552 having catheterreception portions 554 spaced apart by and opposing one another over atransverse band 556. In the illustrated form, the catheter receptionportions 554 have outwardly oriented frusto-conical shapes with centralbores 558 extending longitudinally therethrough. As shown, in FIG. 29,the catheter reception portions 554 can further include retentionstructures 559 that extend radially inward into the central bores 558 tothereby engage and grip a catheter inserted therethrough. In theillustrated form, the retention structures 559 extend in an annularconfiguration around the bore 558 and have a triangular cross-section ina plane extending longitudinally with the bore 558. Of course, othershapes for the catheter reception portions 554 and the retentionstructures 559 can alternatively be utilized. Advantageously, theretention structures 559 can be sized to tightly engage a catheterinserted through the catheter reception portions 554 to thereby preventfluid flow, such as CSF, through the catheter retention portions 554.

The configuration of the device 550 allows the body 552 to lie generallyflat when implanted. As shown, the band 556 includes a central portion560 disposed between the catheter reception portions 554 that includesupwardly protruding ribs 562 or other textured surfaces. The ribs 562extend in a direction generally parallel with longitudinal axes of thebores 558 and are spaced transversely from one another along the centralportion 560. The band 556 further includes tabs 564 that projectlaterally outwardly from the central portion 560. Each of the tabs 564includes an opening 566 extending through and end portion thereof forreception of a suture to fix the device 500 to tissue.

To tighten the device 550 around a catheter, one of the tabs 564 is afemale tab with a slot opening 568 extending therethrough and the otherof the tabs 564 is a male tab including a notch 570 and an elongate neckportion 572. Two or more notches can alternatively be utilized. Asshown, the slot opening 568 of the female tab 564 has a length generallyequal to or slightly larger than the notch 570 and the neck portion 572of the male tab 564, but smaller than a width of the remaining portionsof the male tab 564. Further, the neck portion 572 can have a smallerwidth than the notch 570 so that it can be easily inserted through theslot opening 568. As shown, the central portion 560 can have notches 574on either side thereof on a side of the band 556 with the male tab 564.The notches 574 extend to align with an edge of the bores 558, whichallows the male tab 564 to be flexed along a portion disposed adjacentto the bores 558.

With this configuration, a user can insert a catheter through thecatheter reception portions 554 until the body 552 is positioned at adesired location along the catheter. Thereafter, the user can bend thetabs 564 toward one another over the central portion 560 and thecatheter so that the ribs 562 are distributed about a circumference ofthe catheter. The user can then resiliently deform the slot opening 568and/or male tab 564 and insert the male tab 564 through the slot opening568 until the notch 570 is received within the slot opening 568. Thedevice 550 can be sized and configured so that with the notch 570engaged with the slot opening 568, the ribs 562 tightly engage thecatheter to thereby retain the body 552 on the catheter and prevent thecatheter from migrating without the use of a suture. As with the aboveforms, one of the reception portions 554 can be utilized as a plug toseal with the dura in the opening therethrough to prevent CSF leakage.This is further enhanced by the retention structure 559 preventing fluidflow through the catheter retention portions 554. In one form, the body552 can be composed of silicone 50A.

In one example form, the band 556 can have a length of about 0.89 inchesand a thickness of about 0.06 inches; the suture openings 566 can have adiameter of about 0.07 inches; the bores 558 can have an inner diameterof about 0.05 inches and the retention portions 554 can extend to aninner diameter within the bores 558 of about 0.035 inches; the bores 558and central portion 560 can have a combined width of about 0.58 inches;and the notches 574 can have a width of about 0.02 inches. The body 552can be made from silicone, such as silicone med-4850, or other suitablematerials.

Another example fixation device 600 is shown in FIGS. 32 to 35. Thedevice 600 includes a body 602 having tapered ends 604, such that theends 604 can be utilized as a plug to seal with the dura in the openingtherethrough. The body 602 includes a central bore 606 extendinglongitudinally therethrough. As shown in the figures, the bore 606 caninclude inwardly projecting ribs, rings, or other textured surfaces 608that maximize a catheter engagement surface area and grip with thecatheter. It will be understood that the catheter engagement surfaces ofany of the embodiments described herein can include similar texturedsurfaces to maximize a catheter engagement surface area and grip. In oneform, the interior diameter of the central bore 606 can be sized smallerthan an outer diameter of the catheter so that the body 602 tightlyengages the catheter. The body 602 can be composed of a low durometersilicone.

In a first form shown in FIG. 32, the body 602 can include outwardlyextending tabs 610 having openings 612 extending therethrough. Soconfigured, a user can suture the device 600 in place using the openings612 to prevent the catheter 10 from migrating. In a second form shown inFIGS. 33 and 34, the body 602 can include grooves or annular channels614 extending therearound and the device 600 can further include a clamp616 having grip portions or protrusions 618 configured to be insertedinto the grooves 614 to orient the clamp 616 on the body 502 and preventslippage therebetween. The clamp 616 can be secured over the body 602 toapply compressive pressure on the body 602 and the catheter receivedwithin the body 602. The clamp 616 can have a clam-shell configuration,for example. The device 600 of this form can be sutured in place, suchas through the openings 612 in the tabs 610, around portions of theclamp 616 and/or body 602, or combinations thereof. In an alternativeform shown in FIG. 35, the body 602 can include grooves or annularchannels 620 extending therearound to receive sutures. The grooves 620help the sutures stay in place around the body 602 and can be used tocompress the body 602 to tighten on the catheter therein.

Another example fixation device 700 is shown in FIGS. 36 to 40. Thefixation device 700 of this form includes an elongate main body 702having a tubular configuration with a proximal end 704 and a distal end706. The body 702 has an outwardly bulging intermediate or centralportion 708 and has a tapered profile extending from the central portion708 to the proximal and distal ends 704, 706. The conical profile of theends 704, 706 can advantageously be utilized to act as a plug when auser inserts the respective end 704, 706 into the opening through thedura of a patient. The inwardly tapered profile of the end 704, 706seals with the dura in the opening therethrough to prevent or minimizethe leakage of CSF. If desired, the body 702 can be symmetrical so thatthe proximal and distal ends 704, 706 have similarly tapered profilesand can each be used as a plug. This allows a user to implant the device700 without having to worry about orientation.

As shown in FIG. 40, the body 702 includes a radially-oriented centralopening 712 in the central portion 708 with wings 714 extendinglaterally outward from edges of the opening 712. Each of the wings 714includes an opening 716 extending therethrough so that a user can suturethe device 700 in place using the openings 716 to prevent the catheter10 from migrating. The central opening 712 extends along a longitudinallength of the body 702 exposing a central bore 718 that runstherethrough. In some versions, the one or both of the wings 714 caninclude teeth, ribs, or other textured surfaces 720 extending adjacentto the central opening 712 to grip a catheter 10 inserted within thebore 718.

In some versions, one or both of the ends 704, 706 can be bendable withrespect to horizontal and the remaining portion of the body 702 so thatthe end 704, 706 can be inserted into the dura opening while theremaining portion of the body 702 extends along or lies flat against thefascia. As shown in FIGS. 38 and 39, the opening 712 can be sized toallow the adjacent end 704, 706 to bend and the body 702 can be composedof a flexible material as described herein.

As shown in FIG. 40, the wings 714 include a male wing and a femalewing. The male wing 714 includes an outer tab portion 722 and a waistedportion or notch 724, while the female wing 714 includes a laterallydisposed slot 726 having a first length that extends away from the body702 and a longitudinally disposed slot 728 having a second length thatextends generally parallel with the body 702 adjacent to the centralopening 712 at a base of the female wing 714. The first lengthcorresponds to a largest width of the male wing 714, while the secondlength corresponds to the narrowest width, i.e., the notch 724, of themale wing 714. So configured, the male wing 714 can be twisted so thatthe tab portion 722 aligns with the lateral slot 726 and pulledtherethrough. Thereafter, when a user desires to secure the catheter 10in place, the male wing 714 can be pulled through the lateral slot 726until the notch 724 aligns with the longitudinal slot 728 and twisted sothat the notch 724 of the male wing 714 rests within the longitudinalslot 728.

The fixation device 700 can be provided to a user already partiallyassembled, with the male wing 714 twisted and partially inserted throughthe lateral slot 726. The user can then easily slide the fixation device700 onto the catheter 10 with no or minimal resistance or drag. Once thefixation device 700 is in the desired position, the male wing 714 can bepulled fully through the female wing 714 until the male wing 714 reachesthe secured position (FIG. 36). The user can then suture the wings 714to the fascia or other tissue using the suture openings 716. If thefixture device 700 is being used at the dura, one of the ends 704, 706can be bent (FIGS. 38 and 39) so that the body 702 lies flat against thefascia. The wings 714 can come with a slight bend already built into thedesign for easier anchoring (FIG. 37). The advantage of this design isthat the wings 714 do not need to be in any specific orientation afterbeing secured together to still secure the catheter 10 within the device700. Further, the fixation device 700 does not have to rely on suturesfor securing onto the catheter 10, as the disassembly process would bedifficult if not impossible to do accidentally.

Another example fixation device 800 is shown in FIGS. 41 to 44. Thefixation device 800 of this form includes an elongate body 802 with aproximal end 804 and a distal end 806. The body 802 has an outwardlybulging intermediate or central portion 808. In a first form shown inFIG. 41, the bulging portion 808 has a single, central bulbous portion808 a with a smooth curved profile. In a second form shown in FIG. 43,the bulging portion 808 includes a central bulbous portion 808 a andrings 808 b disposed on either side of the central portion 808 a givingthe body 802 an undulating profile. In both forms, the body 802 can havea tapered profile transitioning from the bulging portion 808 to theproximal and distal ends 804, 806. The tapered profile of the body 802at the ends 804, 806 thereof can advantageously be utilized to act as aplug when a user inserts one of the ends 804, 806 into the openingthrough the dura of a patient. The inwardly tapered profile of the ends804, 806 acts to seal with the dura in the opening therethrough toprevent or minimize the leakage of CSF. As shown, the tapered ends 804,806 taper downwardly so that tips 810 thereof are slightly, e.g.,between about 1 mm to 3 mm, larger than an outer diameter of thecatheter 10 due to a wall thickness of the body 802. If desired, thebody 802 can be symmetrical so that the proximal and distal ends 804,806 have similarly tapered profiles and can each be used as a plug. Thisallows a user to implant the device 800 without having to worry aboutorientation.

As shown in the figures, the body 802 can also include outwardlyextending tabs 812 having openings 814 extending therethrough that allowfor easy placement of sutures to secure the fixation device 800 andcatheter 10 to surrounding tissue. Two tabs 812 can be centrally locatedalong the body 402, as shown, but other configurations and numbers arepossible.

Turning now to FIGS. 42 and 44, the body 802 includes a central bore 816extending longitudinally therethrough along the longitudinal axis L thatis sized to receive a catheter 10. While the device 800 may be suitablefor many purposes in this form, the device 800 can further include oneor more toggle or one-way valves 818 extending across the inner diameterof the central bore 816. The valves 818 are configured to allow thecatheter 10 to only move in a single direction therethrough and, thus,through the body 802. Accordingly, the valves 818 allow a user to insertthe catheter 10 through the body 802, but thereafter resists or preventsretrograde slippage of the catheter 10 through the device 800. In theillustrated form, the valve 818 has a disc-shaped body 820 with acentral aperture 822 and slits 824 extending radially from the centralaperture 820. The body 820 can include an annular cavity 826 sized toreceive edges of the disc-shaped body 820 therein. With thisconfiguration, a user can insert the catheter 10 through the centralaperture 822 of the valve 818. The outer diameter of the catheter 10 islarger than the diameter of the central aperture 822 and, as such,pushing the catheter 10 through the aperture 822 causes wedge portions828 defined by the slits 824 to deflect or flex and engage the catheter10. The deflected wedge portions 828 allow the catheter 10 be fedtherethrough with a minimal amount of friction, but prevent reversemovement by providing holding strength. As shown, the bore 816 caninclude an expanded central portion 830 to allow the valve 818 to easilydeform when the catheter 10 is inserted therethrough. The diameter ofthe central aperture 822 controls the amount of flex in the wedgeportions 828 and the central aperture 822 can guide the catheter 10 tostay within a center of the bore 816. In some versions, the valve 818can be configured to toggle in an opposite direction by overcoming theholding strength of the wedge portions 828, which causes the wedgeportions 828 to deflect in the opposite direction and thereby reversethe holding strength. The advantage of such a toggle valve 818 is toallow a user to insert the catheter 10 through the fixation device 800and slide the fixation device 800 to the intended area on the catheter800. The user would be able to fix the device 800 to the patient withoutlosing adjustability of the catheter's position within the patient orthe fixation device 800. The user is able to set the direction of holdwith the “toggle” feature, which would allow further insertion of thecatheter 10 into the intended area and confidence that the catheter 10would not back out of the intended final position.

With either of the above versions, after a user has implanted thecatheter 10, a user can then advance the fixation device 800 over thecatheter 10 to a final desired position. Then, the user can suture thedevice 800 in place using the openings 814 to prevent the catheter 10from migrating. The device 800 can be sutured in any desired location,including to the fascia at the site of the dura entry, away from thedura, e.g., Scarpa's fascia, in a port pocket, and so forth. In someversions, body 802 can be composed of silicone and can be molded overthe valve 818, which can be composed of PEEK.

Another example fixation device 900 is shown in FIGS. 45 to 49. Thefixation device 900 of this form includes a body 902 having proximal anddistal ends 904, 906 with a bore 908 extending therethrough. One or bothof the ends 904, 906 can have a tapered profile so that the ends 904,906 can advantageously be utilized to act as a plug when a user insertsone of the ends 904, 906 into the opening through the dura of a patient.The inwardly tapered profile of the ends 904, 906 acts to seal with thedura in the opening therethrough to prevent or minimize the leakage ofCSF. As shown, the tapered ends 904, 906 taper downwardly so that tips910 thereof are slightly, e.g., between about 1 mm to 3 mm, larger thanan outer diameter of the catheter 10 due to a wall thickness of the body902. If desired, the body 902 can be symmetrical so that the proximaland distal ends 904, 906 have similarly tapered profiles and can each beused as a plug. This allows a user to implant the device 900 withouthaving to worry about orientation.

The body 902 further includes an outwardly projecting flange 912 havinga plurality of openings 914 extending longitudinally therethrough arounda circumference of the flange 912. As with the above forms, the openings914 can be utilized to secure the device 900 to tissue using one or moresutures. Specifically, after one of the ends 904, 906 is inserted intothe dura opening, a user can secure the flange 912 to the fascia usingone or more sutures. In one example, a purse-string suture can be usedto secure the device 900 to the fascia. In a first form shown in FIG.45, the flange 912 has a circular shape extending outwardly from theproximal and distal ends 904, 906. In a second form shown in FIG. 47,the flange 912 can include slots 916 that extend radially inwardly fromedges thereof. With this form, the flange 912 is divided into wedgeportions 918 that can be flexed independently of one another. Thisconfiguration advantageously allows the wedge portions 918 of the flange912 to be folded over the catheter 10 without excessively projectingoutwardly from the tissue.

As shown in FIG. 45, the proximal and distal ends 904, 906 extend awayfrom the flange 912 in a consistent conical shape. In another version,as shown in FIG. 48, the proximal and distal ends 904, 906 can includewaisted portions 911 extending therearound adjacent to the flange 912.

Turning now to FIG. 49, the central bore 908 can include an expandedcentral portion 920 and a valve 922 disposed thereacross, similar to theabove embodiment of FIG. 44. The valve 922 can be a toggle or one-wayvalve as previously described and the expanded portion 920 can allow thevalve 922 to easily deform when the catheter 10 is insertedtherethrough.

The body 902 can advantageously be utilized to plug the dura opening andsecure to the fascia therearound. If desired, the fixture device 900 canfurther include a catheter securing member 924 that fixes the catheter10 to tissue remote from the dura. The member 924 includes an annularbody 926 with a central bore 928 extending therethrough and tabs 930extending laterally from the body 926. The tabs 930 each include asuture opening 932 extending therethrough. The inner diameter of theannular body 926 can be equal to or slightly smaller than an outerdiameter of the catheter 10 to tightly engage the catheter 10 whendisposed therearound. The member 924 can be composed of a flexiblematerial, such as silicone as described above, so that the member 924can be deformed and easily threaded over the catheter 10. The member 924can be threaded over the catheter 10 to a desired location and secure tothe tissue of a patient at a desired location. When used in combinationwith the body 902, the dura is plugged and the catheter 10 is heldagainst the fascia and prevented from migrating. In some forms, the body902 can be composed of silicone 50A.

It will be appreciated that elements in the figures are illustrated forsimplicity and clarity and have not necessarily been drawn to scale. Forexample, the dimensions and/or relative positioning of some of theelements in the figures may be exaggerated relative to other elements tohelp to improve understanding of various embodiments of the presentinvention. Also, common but well-understood elements that are useful ornecessary in a commercially feasible embodiment are often not depictedin order to facilitate a less obstructed view of these variousembodiments. The same reference numbers may be used to describe like orsimilar parts. Further, while several examples have been disclosedherein, any features from any examples may be combined with or replacedby other features from other examples. Moreover, while several exampleshave been disclosed herein, changes may be made to the disclosedexamples without departing from the scope of the claims.

Those skilled in the art will recognize that a wide variety ofmodifications, alterations, and combinations can be made with respect tothe above described embodiments without departing from the scope of theinvention, and that such modifications, alterations, and combinationsare to be viewed as being within the ambit of the inventive concept.

1. A fixation device for a catheter, the fixation device comprising: anelongate body having a central bore extending therethrough; anintermediate portion of the body having an expanded configuration; andan end of the elongate body having a tapered profile tapering inwardlyfrom the intermediate portion to a distal edge thereof.
 2. The fixationdevice of claim 1, wherein the body further comprises inwardlyprojecting catheter engagement protrusions.
 3. The fixation device ofclaim 1, wherein the expanded configuration comprises one or morebulbous portions extending outwardly from the intermediate portion ofthe body.
 4. The fixation device of claim 1, wherein the end of theelongate body is angled with respect to a longitudinal axis of the bodyor flexible, such that the end is adapted to be used as a plug in anopening in tissue.
 5. The fixation device of claim 1, wherein the bodyis symmetrical, such that an opposite end of the body has a taperedprofile tapering inwardly from the intermediate portion to a distal edgethereof.
 6. The fixation device of claim 1, further comprising at leastone tab projecting outwardly from the body, the at least one tab havinga suture opening extending therethrough.
 7. The fixation device of claim6, wherein the at least one tab comprises a plurality of tabs arrayed inan asymmetrical pattern about the body.
 8. The fixation device of claim6, wherein the at least one tab comprises a circular flange extendingoutwardly from the body, the circular flange having openings arrangedabout a circumference of the circular flange.
 9. The fixation device ofclaim 8, wherein the circular flange further includes slots extendingradially inwardly from edges thereof, the slots defining wedge portionsadapted to be flexed to desired positions around a catheter.
 10. Thefixation device of claim 1, further comprising a valve extending acrossthe central bore and adapted to engage a catheter inserted therethroughto restrict movement of the catheter.
 11. The fixation device of claim10, wherein the valve comprises a one way valve or a toggle valve. 12.The fixation device of claim 10, wherein the central bore comprises anexpanded intermediate portion to allow portions of the valve to deflecttherein due to a catheter being inserted therethrough.
 13. The fixationdevice of claim 1, wherein the body further comprises a longitudinalopening extending along at least a portion thereof; and furthercomprising opposing wings extending laterally outwardly from edges ofthe longitudinal opening, the wings adapted to be secured together. 14.The fixation device of claim 13, wherein the wings include opposinglongitudinally opening slots extending adjacent to the body, the wingsbeing configured to latch together by interlocking the slots.
 15. Thefixation device of claim 13, wherein the wings comprise a male wing anda female wing, the female wing comprising a coupling slot extendinglongitudinally across a width thereof and the male wing comprising anotched portion having a width sized to fit within the coupling slot.16. The fixation device of claim 15, wherein the female wing furthercomprises a second slot extending laterally from the coupling slot, thesecond slot sized to receive the male wing therethrough so that thenotched portion can be positioned within the coupling slot.
 17. Thefixation device of claim 1, wherein the body further comprises one ormore grooves extending around at least a portion thereof.
 18. Thefixation device of claim 17, further comprising a clamp member havingone or more protrusions adapted to be inserted into the one or moregrooves as the clamp member is secured around the body, the clamp memberconfigured to compress the body.
 19. A fixation device for a catheter,the fixation device comprising: an elongate band including a sutureopening extending therethrough, the elongate band including a female endhaving a coupling opening extending therethrough and an opposite, maleend; and a retention portion of the male end configured to be insertedinto the coupling opening of the female end to thereby secure theelongate band around a catheter.
 20. The fixation device of claim 19,wherein the elongate band has a rigid configuration with the male endcurved back over the female end to define an open bore to receive acatheter therein; and the retention portion being configured to snap-fitwithin the slot opening with the male end flexed toward the female endto secure the elongate band to the catheter.
 21. The fixation device ofclaim 19, wherein the elongate band comprises a first elongate band; andfurther comprising: a second elongate band including a suture openingextending therethrough, the second elongate band including a female endhaving a coupling opening extending therethrough and an opposite, maleend; a retention portion of the male end of the second elongate bandconfigured to be inserted into the slot opening of the female end tothereby secure the second elongate band around a catheter; a centralstrip extending longitudinally between and connecting the first andsecond elongate bands together, the male ends of the first and secondelongate bands being disposed on opposite sides of the central strip,such that the device defines a tortuous path for the catheter with theretention portions secured within the respective coupling openings. 22.The fixation device of claim 19, wherein a catheter engagement portionof the elongate band comprises textured surfaces.
 23. A fixation devicefor a catheter, the fixation device comprising: a sleeve member having acentral portion and a bore extending longitudinally therethrough; acollar member having an annular body sized to fit over and compress thecentral portion of the sleeve member; and one or more tabs extendingoutwardly from the collar member, the one or more tabs each having asuture opening extending therethrough.
 24. The fixation device of claim23, wherein the sleeve member further comprises a longitudinal slitextending through a side thereof to the bore, such that the sleevemember can be longitudinally opened to be disposed around a catheter.25. The fixation device of claim 23, wherein the sleeve member furthercomprises retention ends on opposite sides of the central portion. 26.The fixation device of claim 25, wherein the collar member includesportions spaced longitudinally from the retention ends of the sleevemember to define suture gaps therebetween with the collar member mountedtherearound.
 27. The fixation device of claim 25, wherein the retentionends have inwardly tapered profiles.